Status:
UNKNOWN
Childhood Traumas in Obese Women: Association With Deregulation of the Glucocorticoid Axis and Inflammatory State.
Lead Sponsor:
University Hospital, Limoges
Conditions:
Obesity
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
We postulate that childhood traumas are associated with deregulation of the glucocorticoid axis and the inflammatory system in obese women. The main objective of the study is to compare the salivary c...
Detailed Description
Obesity is an epidemic disease whose onset and development factors go beyond the simple energy balance. Current management strategies are often failing. It is therefore important to identify the under...
Eligibility Criteria
Inclusion
- ≥18 years female BMI≥30kg/m2
Exclusion
- History of bariatric surgery
- Any condition or pathology that may influence the corticotropic axis or that may modify the excretion or dosage of cortisol:
- pregnancy, breastfeeding
- hepatocellular insufficiency,
- severe heart failure,
- mild/moderate acute heart failure,
- any psychological disorder not stabilised for at least one year
- alcohol or drug dependence, not weaned for at least one year
- neoplasm under treatment
- Current infectious disease or a history of autoimmune disease (except autoimmune hypothyroidism), inflammatory disease and/or neurodegenerative disease
- Presence of an adrenal adenoma or any known or suspected clinical adrenal or corticotropic disorder
- Subjects with a positive diagnosis of hypercorticism or suspected hypercorticism will also be excluded: 8-hour plasma cortisol after Dexamethasone suppression test (DST) (1 mg dexamethasone taken orally at midnight the previous day) greater than 1.8 microg/100 ml (50 nmol/l)
- antidepressant and neuroleptic treatment, benzodiazepine treatment
- treatment(s) likely to modify the exploration of the corticotropic axis: systemic or local corticosteroid therapy or glucocorticoid infiltration for less than 6 months
- current use of anti-inflammatory drugs or antibiotics
- Shift worker
Key Trial Info
Start Date :
April 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 13 2024
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT05237440
Start Date
April 13 2022
End Date
May 13 2024
Last Update
September 14 2023
Active Locations (1)
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1
LimogesUniversity Hospital
Limoges, France, 87049